| Chapter No | Topics | Questions | Marks |
|---|---|---|---|
| 1 | Introduction | Drug Development Process With schematic representation, discuss integrated drug development process. | 5 |
| 1.1 | Pharmacological approach | Define therapeutic index Short note on Helsinki declaration --- Content provided by FirstRanker.com --- What is LD50? and ED50What is Human Equivalent Dose (HED)? How to convert animal dose to HED? Explain the different pharmacological action studies in the drug development process explain pre-clinical trials write a note ADME profiling --- Content provided by FirstRanker.com --- Define Proof of Conceptdefine maximum tolerated dose Write a note on lead selection and optimization drug development process. | 2 2 2 --- Content provided by FirstRanker.com --- 25 5 5 2 --- Content provided by FirstRanker.com --- 25 |
| 1.2 | Toxicological approach | Importance of chronic toxicity Explain the toxicological approach to drug development process mutagenecity and carcinogenicity Sub acute toxicity | 2 --- Content provided by FirstRanker.com --- 52 2 |
| 1.3 | IND Application | Discuss in detail the IND application What is IND? Enlist the different criteria for IND application | 10 5 |
| 1.4 | Drug characterization | Discuss various drug characterization techniques in drug development process | 5 |
| 1.5 | Dosage form | biopharmaceutical classification of drugs --- Content provided by FirstRanker.com --- name the critical Pharmacokinetic parameter in drug developmentdrug bioavailability Fixed dose combinations Explain the importance of dosage form design in pre-clinical and clinical stages | 2 2 --- Content provided by FirstRanker.com --- 22 5 |
| 2.1 | Introduction Clinical trials | Clinical Development of Drug Requirements to conduct clinical trials as per schedule Y What is clinical trail --- Content provided by FirstRanker.com --- define single blind method | 10 2 2 |
| 2.2 | Various phases of clinical trial | explain inclusion and exclusion criteria in selection of clinical trial subjects define double blind method name different types of clinical trials --- Content provided by FirstRanker.com --- investigation product/drugWhat is Belmont report? Nuremberg trials Explain the role of BPOs in conducting clinical research in India what is 'The Orange Book' --- Content provided by FirstRanker.com --- Note on Non-inferiority clinical studydefine bias Regulations for orphan drugs Regulations for Counterfeit drugs drug labeling requirement in clinical studies --- Content provided by FirstRanker.com --- What is scurvy trail?Discuss in detail the various phases of clinical trial note on randomized clinical trial Briefly explain phase 1 and phase 2 clinical trials write short note on clinical trial design --- Content provided by FirstRanker.com --- define phase Zeroobjectives of phase 1/2/3/4 methods of randomization Note on open labeled clinical trails Methods of sample size calculations in clinical trials --- Content provided by FirstRanker.com --- difference between phase 2a and phase 2bwhat are the objectives of phase 2 studies Use of Placebo in clinical trials principles of trial subject sampling | 5 2 --- Content provided by FirstRanker.com --- 22 2 2 5 --- Content provided by FirstRanker.com --- 22 2 2 2 --- Content provided by FirstRanker.com --- 22 10 2 5 --- Content provided by FirstRanker.com --- 52 5 5 2 --- Content provided by FirstRanker.com --- 25 2 2 2 |
| 2.3 | Methods of post marketing surveillance | Discuss about the different methods of post marketing surveillance --- Content provided by FirstRanker.com --- write a note on case control studiesdifference between retrospective and prospective study observational studies write a note on meta analysis note on cohort studies --- Content provided by FirstRanker.com --- differentiate ADR and ADEretrospective study cross sectional study Epidemiological study Define false positive result with an example | 10 --- Content provided by FirstRanker.com --- 55 5 5 2 --- Content provided by FirstRanker.com --- 22 2 2 2 |
| 2.4 | Abbreviated New Drug Application submission | explain briefly about ANDA submission --- Content provided by FirstRanker.com --- Explain in detail NDA submissionwrite a note on ANDA basic methodology and study designs of BA/BE studies limitations of post marketing surveillance | 10 10 --- Content provided by FirstRanker.com --- 55 2 |
| 2.5 | Good Clinical Practice ICH, GCP, Central drug standard control organization (CDSCO) guidelines | discuss the principles of ICH-GCP guidelines explain clinical trial protocol as per ICH-GCP guidelines Explain Clinical trials and monitoring. Discuss different types of monitoring visits in detail --- Content provided by FirstRanker.com --- What do you mean by expedited reporting in clinical trial? Discuss the safety reporting as per schedule Ydiscuss the recent amendments in schedule Y with special reference to ethics committee what the note on ICH-GCP guidelines essential documents in conducting clinical trials Discuss in detail about CDSCO guidelines --- Content provided by FirstRanker.com --- Role of ICMR in clinical researchlist the guidelines and acts that govern the conduct of clinical trials in India selection and withdrawal of subjects in clinical trail multicentre trails Write a short note on new amendments to Schedule Y. --- Content provided by FirstRanker.com --- what are medical devices and classify with suitable examplespreparative termination of clinical trail statistical design in clinical trails unblinding drug master file --- Content provided by FirstRanker.com --- subject identification codewrite a note on Clinical Study Reports Note on CIOMS Premature Termination or Suspension of a Study ICH E6 --- Content provided by FirstRanker.com --- contract researchclinical trial registries clinical trial insurance comparative studies coding of investigation products --- Content provided by FirstRanker.com --- importance of confidentiality statement in IBPhases of Vaccine Trials | 10 10 10 10 --- Content provided by FirstRanker.com --- 105 5 5 2 --- Content provided by FirstRanker.com --- 22 2 5 5 --- Content provided by FirstRanker.com --- 25 2 2 2 --- Content provided by FirstRanker.com --- 52 5 2 2 --- Content provided by FirstRanker.com --- 22 2 2 2 |
| 2.6 | Challenges in the implementation of guidelines | Non-Therapeutic Study --- Content provided by FirstRanker.com --- Validation of clinical studySelection and recruitment of Study Subjects Clinical Trials with Surgical Procedures / Medical devices. comment on the challenges in the implementation of ethical guidelines | 2 2 --- Content provided by FirstRanker.com --- 55 5 |
| 2.7 | Ethical guidelines in Clinical Research | write a note on clinical data management in clinical trials research involving children Inclusion of pregnant women and nursing mothers in CT? --- Content provided by FirstRanker.com --- vulnerable subjectdefine Ethics Ethical issues involved in Genetic Screening explain clinical trials for vaccines pregnant women as research participant --- Content provided by FirstRanker.com --- Explain the ethical guidelines for clinical researchwrite a note on compensation for clinical Trial subjects as per ethical guidelines Conflict of interest in clinical trials | 10 2 2 --- Content provided by FirstRanker.com --- 22 2 5 5 --- Content provided by FirstRanker.com --- 55 5 |
| 2.8 | Composition, responsibilities, procedures of IRB / IEC | members of ICH explain composition and responsibilities of IRB Discuss in detail about institutional review board | 2 --- Content provided by FirstRanker.com --- 55 |
| 2.9 | Overview of regulatory environment in USA, Europe and India | write on European Clinical Directive function of dcgi Note on 21CFR Part 312 Note on Marketing Authorization Holder (MAH) --- Content provided by FirstRanker.com --- note on centralized marketing and decentralized marketingNote on Clinical Trial Document (CTD MHRA EMEA USFDA --- Content provided by FirstRanker.com --- what are different regulator system in USA, europe and Indiagive an overview of regulatory environment in India expand forms of the following MHRA, CRO, CRF, MAH, EMEA, CTA, GLP, CFR write a note on regulations for OFF-Label Use Write a note on pharmaceutical regulations in regard to clinical trials in European union | 2 --- Content provided by FirstRanker.com --- 22 2 2 2 --- Content provided by FirstRanker.com --- 22 2 5 5 --- Content provided by FirstRanker.com --- 55 10 |
| 2.10 | Role and responsibilities of clinical trial personnel as per ICH GCP | Write a note on Centralized procedure and Decentralized Mutual Recognition Procedure in European union write a note on Accelerated Approval write a note on Accelerated Approval, Fast Track, and Priority Review --- Content provided by FirstRanker.com --- write a note on Fast Track, and Priority Reviewwrite a note on CRA Explain in detail the role and responsibilities of a)investigator b) clinical research associate c) Regulatory authority as per ICH-GCP a. Sponsor/ b. Investigators c. Clinical research associate d. Auditors e. Contract research coordinators f. Regulatory authority explain about clinical trials audit and inspection with special emphasis on national regulatory authorities --- Content provided by FirstRanker.com --- Expand the following: IND, DCGI, PvPI, BPOrole of CRC Role of auditor In clinical data What is an Investigators brochure and explain its content? role and responsibilities of auditors --- Content provided by FirstRanker.com --- explain the role of investigators I clinical trialscriterias for selection of an investigator/s Role and responsibilities of sponsor in clinical trials | 10 5 10 --- Content provided by FirstRanker.com --- 55 10 10 2 --- Content provided by FirstRanker.com --- 22 5 5 5 --- Content provided by FirstRanker.com --- 25 |
| 2.11 | Designing of clinical study documents (protocol, CRF, ICF, PIC with assignment) | Explain in detail the process of designing study protocol in clinical trials. Add a note on importance of CRF CRF, explain designing of CRF with a suitable example crine protocol | 10 5 --- Content provided by FirstRanker.com --- 2 |
| 2.12 | Informed consent Process | Discuss about designing of inform consent form for clinical study? explain confidentiality and impartial witness Explain in detail the informed consent process difference between consent and assent forms explain Waiver of consent | 5 --- Content provided by FirstRanker.com --- 25 2 2 |
| 2.13 | Data management and its components | write a note on QA and QC Discuss data management and its component --- Content provided by FirstRanker.com --- write the application of computers in clinical data managementwrite a note on clinical data archive What is ANOVA? | 5 5 5 --- Content provided by FirstRanker.com --- 52 |
| 2.14 | Safety monitoring in clinical trials | Role of DSMB in safety monitoring Components of documentation form Discuss Electronic Data Processing Explain the monitoring visits in initiation, conduction and closing of clinical trial --- Content provided by FirstRanker.com --- List global ADR reporting Forms?Define unexpected ADR Minimum criteria to report ADR List various criterias to classify a serious ADR write about safety monitoring in clinical trails --- Content provided by FirstRanker.com --- Explain the purpose of the clinical trial monitoring and the responsibilities of monitors in clinical monitoringPVPI PSUR SUSAR write a note on Active Surveillance in ADR reporting --- Content provided by FirstRanker.com --- Role of Eudravigilance in safety monitoringRole of Uppsala monitoring centre (UMC) in safety Monitoring Explain spontaneous reporting of ADR with suitable examples. What are the merits and demerits of spontaneous reporting | 2 2 --- Content provided by FirstRanker.com --- 510 2 2 2 --- Content provided by FirstRanker.com --- 25 5 2 2 --- Content provided by FirstRanker.com --- 25 5 2 10 |
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